Lubricating and/or germicidal composition

ABSTRACT

The present invention is directed to a lubricating and/or germicidal composition, and a method of using the composition as an antiseptic for the hands or as a disinfectant for other inanimate objects, and/or for alleviating or preventing drying of skin. The composition is an alcoholic solution containing cetyl alcohol, glycolic acid, benzalkonium chloride, and a major amount of isopropyl alcohol. In a preferred use, the composition is applied to the surface of the hands as an antiseptic film or &#34;invisible glove&#34; beneath a surgical or other plastic glove to inhibit microbial growth and alleviate drying of the skin.

CROSS-REFERENCE TO RELATED APPLICATION

This is a continuation-in-part of U.S. patent application Ser. No.08/199,335, filed Feb. 22, 1994, to issue as U.S. Pat. No. 5,492,932(Feb. 20, 1996).

BACKGROUND OF THE INVENTION

Bacteria from the hand of a surgeon or other operating room personnelcan be the source of serious infections in surgery patients. Whiletransfer of bacteria is substantially reduced by routine surgicalscrubbing procedures, it is prudent to take additional steps toeliminate bacteria and other microorganisms that may grow under surgicalgloves. If left unchecked, these organisms could escape through an alltoo common puncture to the glove and infect the patient. To this end, agermicidal solution is often coated onto the hands before slipping onsurgical gloves. Optimally, the coating remains on the skin surface ofthe hands during a surgical operation to inhibit bacterial growth ofbacteria. However, current germicidal solutions cause significant dryingof the skin, and do not provide a coating which allows for easy donningor removal of surgical gloves.

Therefore, an object of the present invention is to provide acomposition which is an effective germicide with a high level ofmoisturizing activity on the skin of the user. Another object is toprovide an effective germicidal composition which may be coated ontoskin to provide an antiseptic film which will allow for ready placementand removal of gloves over the skin. Yet another object is to provide acomposition that is useful for lubricating the skin to inhibit drying.

SUMMARY OF THE INVENTION

These and other objects are achieved by the present invention which isdirected to a lubricating and/or germicidal composition, and a method ofusing the composition as an antiseptic lotion for the hands or adisinfectant for inanimate objects, and/or for alleviating or preventingdrying of skin.

The composition contains isopropanol, a germicidally-active quaternaryammonium salt, cetyl alcohol and glycolic acid. The quaternary ammoniumsalt is an effective germicide for vegetative cells, fungi, algae andviruses. The combination of isopropanol and quaternary in the presentcomposition provides substantially instant disinfection of a surface oncontact, and a synergistic effect which increases the effectiveness ofeach of their respective activities as a germicide. In addition, thealcohol provides an initial fast-acting germicidal activity, andevaporates leaving a germicidal residue of the quaternary substantiallyevenly distributed over the surface for a lasting germicidal effect,particularly when the treated surface becomes wet. This feature providesa distinct advantage for retaining the composition on the treatedsurface in the event that the treated surface is contacted with aninfectious material. The germicidal residue remains on the surface andwill retain its activity on an undisturbed surface for up to about 1year, or until the composition is removed by washing the treatedsurface, for example, with conventional soap and water.

The cetyl alcohol and glycolic acid in the composition act incombination to prevent drying of the skin following application of thealcohol and to add lubricity to the composition. The cetyl alcoholfurther acts as an emollient and emulsion modifier in the composition.The glycolic acid is a newly recognized cosmetic additive withmoisturizing properties.

The invention further provides a method of inhibiting microbial growthon a substrate by contacting the surface of the substrate with thegermicidal composition. The composition may be used as a disinfectantfor countertops and other inanimate objects, or as an antiseptic lotionwhich is applied to the hands or other skin surface. The compositionforms a protective germicidal barrier when applied to the skin or otherhard surface. In a preferred use, the composition is used in conjunctionwith gloves or other protective outerwear that are utilized, forexample, by a surgeon or other health care provider, a food handler, andthe like. The composition provides a moisturizing germicidal film on thesurface of the skin which act as an antiseptic "invisible glove" beneatha surgical or other plastic glove. In another preferred use, thecomposition is used for lubricating the skin to alleviate or preventdrying.

The invention also contemplates an article of manufacture, or kit, foruse in inhibiting microbial growth on a substrate. The kit is composedof, in combination, the germicidal composition packaged withincontaining means, optionally with instruction means comprisinginformation for the use of the composition and/or other relatedliterature, a pair of surgical glove or other outerwear, and/or a clothor other material for applying the composition.

DETAILED DESCRIPTION OF THE INVENTION

The invention provides a topical, lubricating and/or germicidalcomposition for applying to a substrate such as the hands or aninanimate object. The composition is an alcoholic solution containingcetyl alcohol, glycolic acid, benzalkonium chloride, and a major amountof isopropyl alcohol. The composition is an effective germicide againstbacteria, fungus, yeast, and viruses, and/or for alleviating orpreventing drying of the skin of the user.

Cetyl alcohol, a C₁₆ fatty alcohol, is included in the composition as anemulsifier and as a lubricant to allow gloves to be more easily slippedonto and off of the hands. The composition contains about 1-25 wt-%cetyl alcohol, preferably about 1-15 wt-%, preferably about 1-10 wt-%,preferably about 2-3 wt-%, preferably about 1.5-2.5 wt-%, morepreferably about 2.5 wt-%.

The composition includes an effective bactericidal amount ofbenzalkonium chloride, a quaternary ammonium antimicrobial agent that iscommercially available, for example, as Zephiran® chloride (Winthrop),17% concentrate. The alkyl groups of the quaternary range from C₈ toC₁₈. The composition includes about 0.1-1.5 wt-% of the 17% solution ofbenzalkonium chloride, preferably about 0.1-1 wt-%, preferably about0.1-0.8 wt-%, preferably about 0.1-0.5 wt-%, more preferably about0.13%.

The composition is formulated with a major amount of isopropyl alcohol.Although not intended to limit the scope of the invention, it isbelieved that the isopropyl alcohol enhances the germicidal action ofthe remaining ingredients, particularly the bactericidal effects of thebenzalkonium chloride. The isopropyl alcohol also provides for an evendistribution of the ingredients over the skin or other substrate. Thecomposition includes about 60-98% isopropyl alcohol, preferably about70-98%, preferably 80-98%, more preferably about 90-98%, more preferablyabout 95%.

Surprisingly, it has been found that the combination of cetyl alcoholand glycolic acid with the other named ingredients provides acomposition having a high level of germicidal activity with increasedlubricating effects which enhance the feel of the composition on theskin of the user. The glycolic acid and cetyl alcohol act to preventdrying of the skin by the isopropyl alcohol in the composition. Toachieve this level of activity, the composition includes an effectivelubricating amount of glycolic acid, preferably about 0.1-3 wt-%,preferably about 0.1-1 wt-%, preferably about 0.1-0.4 wt-%, preferablyabout 0.2-0.4 wt-%, preferably about 0.2-0.3 wt-%, more preferably about0.25 wt-%.

The composition may optionally include minor amounts of additive agentsfor specific uses as desired. The composition contains the ingredientsin a concentration such that dilution by water on the skin or in spillsof contagious material will not diminish or interfere with itseffectiveness as a germicide.

The concentration of ingredients in the composition is effective todecrease the microbial count on the skin or other substrate by about95-100% within about 5-40 seconds after contact, more preferably withinabout 5-10 seconds.

In a preferred embodiment of the invention, the composition isformulated with about 1-3 wt-% cetyl alcohol, about 0.1-0.4 wt-%glycolic acid, about 0.1-1 wt-% benzalkonium chloride, and about 90-98wt-% isopropyl alcohol.

The present compositions exhibit improved efficacy as a combinationgermicide and moisturizing lotion, and have particular usefulness as anantiseptic lotion applied to the hands or other skin surfaces. Themixture of ingredients synergistically provide a germicidal effect andan improved moisturizing effect on the skin. The composition alsoenables gloves, such as surgical gloves and the like, to be more easilyslipped over the skin.

The composition when dried on the skin remains intact as a film andprovides a persistent residual germicidal coating on the surface of theskin until washed off. The composition may be removed by washing with acommercial hand soap or other like detergent. On a hard surface,undisturbed, the germicidal residue can last up to about one year.

The compositions are an effective germicide against a wide assortment ofmicroorganisms. The composition is effective in destroying gram-negativeand gram-positive organisms on contact. For example, the composition maybe used as an effective bactericide, for example, against Staphylococcusaureus, Staphylococcus epidermidis, Salmonella cholerasuis, Escherichiacoli, Klebsiella pneumoniae, Listeria monocytogenes, Streptococcuspyogenes, Enterobacter agglomerans, Serratia marcescens, Legionellapneumophila, Leucothrix mucor, and Mycobacterium tuberculosis, and thelike. The composition provides effective fungicidal action againstorganisms such as Candida albicans, Trichophyton mentagrophytes,Aspergillus niger, Myrathecium verrucaria, Trichoderma viride,Chaetomium globosum, and the like. The composition is also an effectivealgicide against algae such as Stigeoclonium spp., Oscillaturia tenuis,Anacystis cylindrica and other like blue-green algae, and the like. Inaddition, the composition possesses effective virucidal activity againstsuch viruses as hepatitis B virus, rhinovirus, parainfluenza virus,adenovirus, rabies, and human immunodeficiency virus (HIV), hydrophilicviruses such as Coxsackie virus, echo virus, and poliovirus, lipophilicviruses such as herpes simplex, vaccinia virus, and influenza virus,,and the like. It is also effective in destroying cysts of protozoa suchas Entamoeba histolytica.

The compositions are generally prepared by combining the ingredients ina suitable mixing vessel. The ingredients may be added simultaneously orsequentially, and mixed together to form an alcoholic solution. Thecompositions may be prepared at about room temperature (25° C.), and arestable for up to about 6-12 months when stored at about room temperature(25° C.).

The germicidal compositions of the invention are advantageously used bypersons whose occupation requires them to wear gloves, for example, asurgeon, food handler, hair dresser, and the like. In use, thecomposition is applied topically to the hands, preferably following apre-operative scrub-up or other hand wash with a detergent orantiseptic. The isopropyl alcohol is allowed to evaporate, wherein afilm-like coating is formed on the surface of the skin. The compositionremains on the surface of the skin for a period of time until washedoff.

Advantageously, the composition may be retained on the skin to provide acontinuous residual germicidal action over an extended period of timeuntil washed off. To achieve such extended germicidal activity, a glovemade of plastic, latex, rubber and the like, for example, a surgicalglove, or other like outerwear, may be placed over the dried compositionon the skin. The combination of ingredients provides a composition whichwill form a film on the skin surface which is smooth and slippery to thetouch to allow gloves to be more easily slipped on and off the hands,thus facilitating a handling step where accidental bacterialcontamination could occur. In addition, the ingredients, particularlythe glycolic acid, reduces dehydration of the skin from wearing glovesover an extended period of time.

The composition may also be used as a disinfectant to disinfectinanimate objects such as countertops, examination tables, especiallyafter spills of infectious material in a hospital or laboratory settingwhere hazardous wet spills are frequently encountered, and the like. Inuse, the substrate to be disinfected is contacted with the compositionby spraying, wiping with a cloth or sponge, submersion in a container ofthe composition, and the like. The composition is allowed to remain onthe surface of the object until it evaporates. The germicidalcomposition may remain on the object, or may be removed either by wipingor rinsing with soap and water. Additionally, the composition may beused as a rapid spray on hazardous spills of patient secretions,excretions, blood, and the like.

The germicidal composition may be packaged as an article of manufacture,or kit, for use in disinfecting inanimate objects and as an antisepticlotion on skin surfaces. The kit includes, the composition packagedwithin containing means, for example, a foil or plastic pouch, or avial, jar or other like container, optionally with means for spraying,or impregnated in a packaged absorbent fibrous or cellular sheetmaterial which may be dropped, pressed, or rubbed onto the surface ofthe skin or object to release an effective amount of the compositionthereon, and other like containers. The kit may further includeinstruction means composed of information relating to the use of thecomposition, pharmaceutical information, and other like literature,and/or, gloves such as surgeons gloves, and/or a cloth, tissue or othercellulosic material for spreading the composition onto a hard surface.The instruction means may be in the form of a label or tag attached tothe packaging, or a printed package insert within the packaging and thelike.

The invention will be further described by reference to the followingdetailed examples, wherein the methodologies are as described below.These examples are not meant to limit the scope of the invention thathas been set forth in the foregoing description. Variation within theconcepts of the invention are apparent to those skilled in the art. Thedisclosures of the cited references are incorporated by referenceherein.

EXAMPLE I Preparation of Germicidal Lubricating Lotion

A germicidal composition was prepared with the ingredients as shown inTable I, below.

                  TABLE I                                                         ______________________________________                                                        AMOUNT  WEIGHT %                                              ______________________________________                                        Cetyl Alcohol     2000    gm    2.5%                                          Zephiran Concentrate (17%)                                                                      (615    ml)   0.13%                                                           104.55  gm                                                  Glycolic Acid     200     gm    0.25%                                         Isopropyl Alcohol Q.S.                                                                          80,000  ml    96%                                           ______________________________________                                    

To prepare a germicidal lotion, 2000 grams cetyl alcohol (Ciba-GeigyCorp., Woodbridge, N.J.), 250 grams glycolic acid (hydroxyacetic acid;Aldrich Chemical Company) and 615 ml benzalkonium chloride (Zephiranchloride, concentrate, 17%; Winthrop Pharmaceuticals, New York, N.Y.)were dissolved in isopropyl alcohol (99%) and mixed at room temperatureuntil enough isopropyl alcohol was added to the mixture to form a 80liter solution.

The final composition contained 2.5% cetyl alcohol, 0.13% benzalkoniumchloride, 0.25% glycolic acid, and 96% isopropyl alcohol (99%).

EXAMPLE II Use of the Germicidal Lubricating Lotion as an Antiseptic

The composition prepared in Example 1 was applied to the surface of thehands to test its effectiveness against normal skin flora such asstaphylococci, micrococci, and diphtheroids.

Samples of bacteria were taken from the surface of the hands prior toapplication of the composition. The composition (1-2 ml) was sprayedonto the hands as a thin coating. The isopropyl alcohol evaporatedwithin 2-4 seconds, and the composition formed as an even, inconspicuousfilm on the skin surface. After 1.5 hours, samples were again taken fromthe skin surface. The bacterial counts before and after applying thecomposition is shown in Table II below.

                  TABLE II                                                        ______________________________________                                                    FINGER TIPS                                                                            FINGER TIPS                                                          LEFT HAND                                                                              RIGHT HAND                                               ______________________________________                                        Pre-Treatment 102        37                                                   Post-Treatment.sup.1                                                                         5          1                                                   % Reduction       95%       97%                                               ______________________________________                                         .sup.1 Following wetting of the hand with 1-2 ml of the composition and       allowing the composition to air dry.                                     

What is claimed is:
 1. A composition, comprising:(a) about 1-25 wt-%cetyl alcohol; (b) an effective lubricating amount of glycolic acid; (c)an effective bactericidal amount of benzalkonium chloride; and (d) amajor amount of isopropyl alcohol; the combination of isopropyl alcohol,glycolic acid and benzalkonium chloride being germicidally effective. 2.The composition according to claim 1, comprising about 1-10 wt-% cetylalcohol.
 3. The composition according to claim 1, comprising about 0.1-3wt-% glycolic acid.
 4. The composition according to claim 3, comprisingabout 0.2-0.3 wt-% glycolic acid.
 5. The composition according to claim1, comprising about 60-98% isopropyl alcohol.
 6. The compositionaccording to claim 1, comprising about 90-98% isopropyl alcohol.
 7. Thecomposition according to claim 1, comprising about 0.1-1.5 wt-%benzalkonium chloride.
 8. The composition according to claim 7,comprising about 0.1-0.5 wt-%, benzalkonium chloride.
 9. The compositionaccording to claim 1, wherein the composition is effective in inhibitingthe growth of a microorganism selected from the group consisting ofgram-positive bacteria, gram-negative bacteria, fungi, viruses, alga,and any combination thereof.
 10. The composition according to claim 1,wherein the composition is effective in alleviating or preventing dryingof the skin.
 11. The composition according to claim 10, wherein thecomposition is effective against a bacteria selected from the groupconsisting of Staphylococcus aureus, Staphylococcus epidermidis,Salmonella cholerasuis, Escherichia coli, Klebsiella pneumoniae,Streptococcus pyogenes, Enterobacter agglomerans, Serratia marcescens,Legionella pneumophila, Listeria monocytogenes, Leucothrix mucor,Mycobacterium tuberculosis, and any combination thereof.
 12. Thecomposition according to claim 11, wherein the composition is effectiveagainst a fungus selected from the group consisting of Candida albicans,Trichophyton mentagrophytes, Aspergillus niger, Myrathecium verrucaria,Trichoderma viride, and Chaetomium globosum, and any combinationthereof.
 13. The composition according to claim 11, wherein thecomposition is effective against an alga selected from the groupconsisting of Stigeoclonium spp., Oscillaturia tenuis, any Anacystiscylindrica.
 14. The composition according to claim 11, wherein thecomposition is effective against a virus selected from the groupconsisting of rhinovirus, parainfluenza virus, adenovirus, rabies, humanimmunodeficiency virus, Coxsackie virus, echo virus, poliovirus, herpessimplex, vaccinia virus, influenza virus, and any combination thereof.15. The composition according to claim 11, wherein the composition iseffective against Entamoeba hystolytica.
 16. The composition accordingto claim 1, comprising:(a) about 1-25 wt-% cetyl alcohol; (b) about0.1-3 wt-% glycolic acid; (c) about 0.1-1.5 wt-% of benzalkoniumchloride; and (d) about 60-98 wt-% isopropyl alcohol.
 17. A method ofdisinfecting skin, comprising:contacting the skin with the compositionof claim
 1. 18. The method according to claim 17, wherein the methodfurther comprises:allowing the composition to dry to a film on the skin;and maintaining the composition on the skin for a time effective todeliver a germicidal effect to the skin.
 19. The method according toclaim 17, wherein the substrate is the skin of a hand, and the methodfurther comprises applying a glove onto the hand over the composition.20. A method of lubricating and inhibiting drying of skin, comprising:contacting the skin with the composition of claim
 1. 21. The methodaccording to claim 20, further comprising:allowing the composition todry to a film on the skin; and maintaining the composition on the skinfor a time effective to deliver a lubicating effect to the skin.
 22. Anarticle of manufacture comprising the composition of claim 1 packagedwithin containing means, and instruction means for using the compositionfor inhibiting the growth of a microorganism on human skin or aninanimate object, or for lubricating the skin to inhibit drying, or acombination thereof.
 23. The article according to claim 22, wherein thecontaining means is selected from the group consisting of a vial, jar,pouch, absorbent fibrous sheet, or any combination thereof.
 24. Thearticle according to claim 23, wherein the containing means comprisesmeans for spraying.
 25. The article according to claim 22, wherein theinstructions means is a label or tag attached to the packaging, aprinted package insert, or a combination thereof.
 26. The articleaccording to claim 22, further comprising a plastic glove, a materialfor applying the composition to a substrate, or a combination thereof.